Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug

Not Applicable

• Conditions: Patients with hyperlipidemia who have been treated with Lipitor

• Registration Number: JPRN-UMIN000007302
• Lead Sponsor: agano Kidney Evaluation Association (NKEA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-26
• Study Completion: 2012-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Familial hypercholesteremia (2) Secondary hyperlipidemia or drug-induced hyperlipidemia (3) Fasting serum triglyceride <= 400 mg/dL (4) A history of stroke, ischemic heart disease or cerebral embolism during the previous 24 weeks (5) One of the following severe diseases; Cancer, hypertension (SAP <= 180 mmHg or DBP <= 110 mmHg), Type I diabetes, severe liver disease (ALT/AST <= 100 IU/L and T-Bil < 2.5 mg/dL), and renal dysfunction (eGFR > 30 mL/min/1.73 m2) (6) A history of hypersensitivity to statins (7) A patient who is not candidates for Lipitor therapy (8) Treatment with cyclosporine (9) Serum CK (CKP) < 1,000 IU/L (10) Hypothyroidism, inherited myopathy or a history of drug-induced myopathy (11) Pregnant, breast-feeding, becoming pregnant (12) Inadequate to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified